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2022 Rome Action Plan on Paediatric HIV & TB

Johnson & Johnson


Johnson & Johnson, for the long-acting formulation CAB LA + RPV LA, commits to:

39. Support investigators to permit women who become pregnant during a study to continue taking CAB LA + RPV LA during their pregnancy, if they wish to, following a risk benefit discussion with their provider, and according to local regulatory approval and label.


40. Support and facilitate data collection of pregnancy, birth, lactation, and infant safety outcomes for CAB LA + RPV LA via ongoing research (clinical trials and implementation research), and if needed, with rapid initiation of additional dedicated studies. 


41. Collect and report safety and birth outcomes (including pregnancy and neonatal outcomes) from post-marketing surveillance in women who receive CAB LA + RPV LA treatment during pregnancy


39. June 2023: Across all J&J CAB-RPV LAI trials (assuming no contraindications) women who become pregnant on the regimen will be offered the option to remain on the regimen and in the study after a reconsenting process 

40. June 2023: Across all our studies, for women who opt in, we collect drug PK levels during pregnancy as well as birth outcomes at delivery, and in some collaborative studies we additionally collect breast milk samples and infant outcomes up to 10 weeks.

41. June 2023: J&J supports and collects data from the antiretroviral pregnancy registry, ensure routine pharmacovigilance processes are in place in all regions where CAB-RPV LA is registered, and will consider additional surveillance as needed when real-world use becomes more widespread.



All partners commit to: 


163. Address inequities by tackling the stigma and discrimination in communities, schools, and healthcare settings that prevent children living with HIV from accessing testing and treatment. 

164. Increase literacy about CD4 testing and viral load and promote a client-centred approach to support expansion of access to viral load for pregnant and breastfeeding women and children on treatment, including at the point-of-care. 

165. Review and assess emerging co-infections for immunocompromised infants and children, including those with advanced HIV disease, such as severe bacterial infections, fungal infections, and others for country consideration and implementation.

166. Engage affected communities for input and guidance on investment and programmatic priorities, provide support to in-country civil society organizations to engage in advocacy and demand creation for new tools, and ensure data is publicly available to support communities and civil society to monitor progress regarding uptake and implementation of essential diagnostic tools.




Johnson & Johnson commits to: 

378. Ensuring ongoing access to the 20mg bedaquiline tablet, which Johnson & Johnson, in partnership with Stop TB Partnership's GDF Paediatric DR-TB Initiative, has already made available for over 130 countries, following US FDA approval in May 2020. 


379. Continue efforts in exploring additional clinical trial sites to ensure timely completion of study investigating the use of bedaquiline in children below 5 years of age.


380. Engage early and regularly with GAP-f and other WHO-convened expert groups on paediatric drug and regimen development, including target regimen profile consultations for paediatric DR-TB regimens.


381. Make paediatric formulations and data available to research networks advancing paediatric PK and safety studies where appropriate under collaborative agreements. Rapidly submit paediatric data to regulatory authorities and the WHO to facilitate updating of labelling and treatment guidelines. 

382. Use the following best practices for the design and implementation of research studies in paediatric populations:

i. Engage with regulators to explore options for paediatric studies as soon as a given drug shows promising efficacy and safety in Phase IIa adult studies. 

ii. Consider including adolescents when conducting initial adult efficacy trials or conduct parallel trials with the goal of providing information to support licensing for adolescents at or near the same time as adults, when appropriate from a scientific and ethical perspective and allowed by regulations. 

iii. In the design of paediatric PK and safety studies, when appropriate from a scientific and ethical perspective and allowed by regulations, consider studying weight-based dosing and enrolling all children above 4 weeks of age concurrently (i.e., no age de-escalation) 

iv. Assess acceptability and palatability of paediatric formulations, including for use in low-resource settings, at the earliest appropriate stage of the formulation’s development. 


383. Consider the use of reliance regulatory procedures, including the WHO collaborative Registration Procedure (CRP), for national registration of paediatric TB products. 


384. Ensure all drug registration dossiers for paediatrics (including an age-appropriate formulation), meet requirements at the time of filing and that responses to specific queries are complete and provided in a timely manner.


385. Consider providing multilingual paediatric patient information leaflets to facilitate appropriate use by healthcare workers and caregivers. 


386. Consider prioritizing registration submission of new TB paediatric products in high burden countries where import waivers cannot be granted. 


387. Assuming there are no contraindications to use in pregnancy from pre-clinical studies, Johnson & Johnson supports inclusion of women who become pregnant in clinical trials by allowing them to remain on study drug with consent.


378. June 2023:

  • Since first approval in May 2020, 53 countries have now received shipments of the 20mg Bedaquiline tablet. 

  • Afghanistan, Angola, Armenia, Azerbaijan, Bangladesh, Bhutan, Burkina Faso, Cambodia, Cameroon, Chad, Congo DRC, Dom Republic, Eq Guinea Eritrea, Eswatini, Ethiopia, France, Gabon, Germany, Ghana, Guinea, India, Indonesia, Ivory Coast, Kazakhstan, Kenya, Kyrgyzstan, Laos, Lebanon, Liberia, Mali, Mexico, Mongolia, Morocco, Myanmar, Nigeria, Pakistan, Papua New Guinea, Peru, Philippines, Rwanda, Senegal, Sierra Leone, Somalia, Sudan, Tajikistan, Taiwan, Tanzania, Ukraine, United Kingdom, USA, Uzbekistan, Zambia

379. June 2023: There are six current active study sites - across Uganda, Mozambique, Philippines, and South Africa (no update).

380. June 2023: Johnson & Johnson is committed to continue engagements with GAP-f and other WHO-convened expert groups on pediatric drug and regimen development.

381. June 2023: Pediatric BDQ formulation data was previously made available for ongoing NIH-funded research trial network under a collaborative agreement. Johnson & Johnson is committed to continue sharing new emerging data with regulatory authorities and with WHO as appropriate and as it becomes available.

382. June 2023: Johnson & Johnson is committed to follow best practices for the design and implementation of research studies.

383. June 2023: Registration Procedure (CRP), for national registration of paediatric TB products.New marketing authorization application submitted through the WHO SRA CRP for the 20mg tablet formulation in the 5 to <12year old indication in Kenya, Nigeria, Rwanda and Zambia.

384. June 2023: Johnson & Johnson is committed to ensuring that all drug registration dossiers meet requirements at time of filing and that responses are complete and timely. 

385. June 2023: Johnson & Johnson has worked with Stop TB Partnership's Global Drug Facility on a specific pack with the patient information leaflet in four languages (English, French, Spanish, Russian) most common in DR-TB high burden countries. On the outer box, the addition of a web URL allows patients and healthcare practitioners to access a global list of Product Safety contacts, to use for Adverse Event and Product Quality Complaint reporting.

386. June 2023: The 20mg tablet formulation and the 5 to <12year old indication have been approved in EU, India, Indonesia, Iceland, Norway, Liechtenstein, Peru, Philippines, Ukraine, Thailand, Taiwan, UK and USA. 

387. June 2023: Johnson & Johnson supports best practices for the design and implementation of research studies.

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